On 22 ndJune 2017, the U.S. Food and Drug Administration (FDA) granted approval to Rituxan Hycela™, a combination of rituximab and hyaluronidase human, for the subcutaneous treatment of adult patients with previously untreated and Relapsed or Refractory (R/R) Follicular Lymphoma (FL), previously untreated Diffuse Large B-cell Lymphoma (DLBCL), and previously untreated and previously treated Chronic Lymphocytic Leukemia (CLL). 1
Rituxan Hycela™ is a novel co-formulation of the same monoclonal antibody as Intravenous (IV) rituximab (Rituxan), along with the molecule hyaluronidase human, an enzyme which aids the delivery of rituximab under the skin.
The approval granted by the FDA is based on results from four clinical studies consisting of nearly 2,000 patients including;
- The SABRINA study ( NCT01200758), a phase III randomized study which accessed the pharmacokinetics, efficacy and safety of Rituxan Hycela™ versusIV rituximab in previously untreated FL patients (read more here)
- The SAWYER study ( NCT01292603), a phase Ib randomized study which compared the safety and pharmacokinetics of Rituxan Hycela™ versusIV rituximab in combination with chemotherapy in previously untreated CLL
- The MabEase study ( NCT01649856), a phase III randomized study evaluating the safety and efficacy of Rituxan Hycela™ versusIV rituximab in combination with chemotherapy in previously untreated DLBCL
- The PrefMab study ( NCT01724021), a phase III randomized study which evaluated the patient preference with Rituxan Hycela™ versus IV rituximab in previously untreated FL and DLBCL
In these studies, Rituxan Hycela™ had a comparable clinical efficacy and resulted in non-inferior levels of rituximab in the blood compared to IV rituximab. Furthermore, results from the PrefMab study revealed that most previously untreated DLBCL and FL patients preferred the subcutaneous administration of rituximab compared to the IV administration. 2
Additionally, the incidence of Adverse Events (AEs) were similar with those observed with IV rituximab, with the exception of local skin reactions. In FL patients, the most common AEs observed included infections, neutropenia, nausea, constipation, and fatigue. In DLBCL patients, the most common AEs included infections, neutropenia, hair loss, and anemia. For CLL patients, the most common AEs observed included infections, neutropenia, nausea, thrombocytopenia, fever, vomiting, and erythema at the injection site. 1
Genentech, the drug manufacturer, noted that this newly approved Rituxan Hycela™ can be administered under the skin within “minutes instead of hours through IV infusion” of rituximab. Patients can only receive Rituxan Hycela™ after one full dose of IV rituximab.